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Stapler Post-market Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922205
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Duomed

Brief Summary:
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Condition or disease Intervention/treatment
Observational Device: Endoscopic Linear Cutter Stapler and reloads

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
RYGB surgery
Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.
Device: Endoscopic Linear Cutter Stapler and reloads
Endoscopic Linear Cutter Stapler and reloads




Primary Outcome Measures :
  1. Number of patients with adverse events related to the index-procedure. [ Time Frame: 1 month follow-up ]
    Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  2. Number of patients with adverse events related to the index-procedure. [ Time Frame: 6 months follow-up ]
    Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.


Secondary Outcome Measures :
  1. Number of adverse device effects. [ Time Frame: 1, 6, 12 and 24 month follow-up ]
    Determination of staple line disruption.

  2. Number of patients with bariatric surgery related re-interventions. [ Time Frame: 1, 6, 12 and 24 month follow-up ]
  3. Percentage of excess weight loss. [ Time Frame: 1, 6, 12 and month follow-up ]
    pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).

  4. Questionnaire on food tolerance. [ Time Frame: 1, 6, 12 and 24 month follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.
Criteria

Inclusion Criteria:

  • Age at study entry is at least 18 years.
  • Patient must sign and date the informed consent form prior to the index-procedure.
  • Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
  • Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria:

  • Patient is pregnant.
  • History of bariatric surgery.
  • Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922205


Contacts
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Contact: Dorien Haesen 0032470219703 dorien.haesen@archerresearch.eu

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Hans Verhelst, Dr.    +32 89 32 60 20    hans.verhelst@zol.be   
Sponsors and Collaborators
Duomed
Investigators
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Principal Investigator: Hans Verhelst, Dr. ZOL, Genk

Additional Information:

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Responsible Party: Duomed
ClinicalTrials.gov Identifier: NCT02922205    
Other Study ID Numbers: ST-01
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No